NSAI Notified Body Designation to the In Vitro Diagnostic Regulation (IVDR) 2017/746
NSAI is proud to announce that we have achieved designation under the In Vitro Diagnostic Regulation 2017/746.
NSAI is now able to provide conformity assessments under the IVDR and grant CE marked certificates to the scope documented on the NANDO database. NSAI will be performing conformity assessment activities under IVDR 2017/746, Annex IX Chapter I and Chapter II.
The Designation represents a significant expansion in the scope of conformity assessment provided under the old IVDD. In line with this expansion, NSAI is designated to perform conformity assessment activities for all Classifications of devices: Class A, Class B, Class C and Class D.
NSAI’s IVDR scope of Designation includes, but is not limited to:
• Devices intended to be used to determine markers of the specific blood grouping systems.
• Devices intended to be used in screening, diagnosis, staging or monitoring of cancer.
• Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents.
• Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging.
• Devices intended to be used for detection of pregnancy or fertility testing.
• Devices which are controls.
• Devices intended to be used for self-testing.
In accordance with Annex IX and MDCG 2019-13, NSAI will be performing sampling on Class B and Class C devices.
NSAI will be accepting applications for Class D devices. Applications will require case-by-case assessment and agreement between manufacturers and NSAI until such time as European Union Reference Laboratories (EURLs) become designated and operational. NSAI is committed to supporting Class D manufacturers in finding a route to market.
NSAI has achieved this designation ahead of the average designation timeline. We are excited to work with manufacturers to provide a high-quality conformity assessment service and are proud to be part of the European framework facilitating patient access to essential devices.
For manufacturers wishing to engage under the IVDR, please contact Sales.Medical@nsai.ie
